The Revised USP Sterile Compounding Standards Article CE# 05-115-19-063-RN
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The Revised USP Sterile Compounding Standards Article CE# 05-115-19-063-RN

On June 1, the United States Pharmacopeia (USP) released the long-awaited final revisions to General Chapters <797> Pharmaceutical Compounding - Sterile Preparations, and <795> Pharmaceutical Compounding - Nonsterile Preparations. USP also released a newly developed Chapter <825> regarding the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals. 

While standards are living documents subject to further modification, this release aligned several chapters, including Chapter <800> - Hazardous Drugs—Handling in Health Care Settings, with an effective date of December 1, 2019. To reach this point, the USP Compounding Expert Committee reviewed over 8,000 comments in a revision process that spanned a multi-year timeframe and included two draft revisions to solicit input from a wide range of stakeholders.

Meeting or exceeding USP <797>—it is designed to be a minimum standard—is a key component in ensuring patient safety and a significant step toward compliance with state and federal regulations, accreditation standards, and other requirements for legal and ethical pharmacy operations. All providers are strongly encouraged to download and familiarize themselves with the standards. This article will summarize the major changes between the current standard and the final revision and explain how and when to apply the standards in Chapter <797> when preparing compounded sterile products (CSPs) used in home infusion and other alternate infusion settings. Compounding personnel and persons who are responsible for the operation of a compounding facility are highly encouraged to read the chapter in its entirety as this article does not capture every aspect of the standard, rather it focuses on areas most applicable to home infusion.


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